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FDA 510(k) Application Details - K111863
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
More FDA Info for this Device
510(K) Number
K111863
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
MATERIALISE N.V.
15 TECHNOLOGIELAAN
LEUVEN 3001 BE
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Contact
ALAXANDRA RAZZHIVINA
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Regulation Number
888.3350
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Classification Product Code
JDI
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More FDA Info for this Product Code
Date Received
06/30/2011
Decision Date
06/15/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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